Bristol-Myers Squibb Company will conduct clinical studies to assess the safety and efficacy of Glucovance (glyburide and metformin hydrochloride tablets) in children aged 10 and over with type 2 diabetes. The company is initiating the Glucovance studies based on a written request from the U.S.
Food and Drug Administration (FDA) under recent pediatric research legislation and as a part of the company's ongoing commitment to develop new treatment options for the growing number of children with type 2 diabetes. Glucovance, which was originally approved by the FDA on July 31, 2000, is a unique oral antidiabetic that represents a new and innovative approach to managing type 2 diabetes. Glucovance is the first oral antidiabetic medication to simultaneously treat the multiple defects of type 2 diabetes in a single pill.
"In 1998, Bristol-Myers Squibb launched an extensive clinical research program to evaluate the benefits of our widely prescribed diabetes pill, Glucophage, in pediatric patients," said Richard J. Lane, president, Bristol-Myers Squibb Worldwide Medicines Group. "As a result of this research, the FDA recently approved Glucophage as the first alternative to insulin for children 10 years of age or older with type 2 diabetes. We are pleased to have the opportunity to once again work with the FDA and the pediatric community to investigate the use of our unique oral diabetes pill, Glucovance, in this patient population. Through this research, we hope to be able to provide physicians with additional new treatment options to address this growing health concern."
Until recently, type 2 diabetes was thought to be a disease that affected middle aged and older adults. However, a recent American Diabetes Association consensus report indicates up to a 10-fold increase in the incidence of type 2 diabetes in children during the past 10 years. Until the approval of Glucophage in December 2000, the only FDA-approved treatment for children with type 2 diabetes was injectable insulin.
Glucovance works differently than other type 2 diabetes medications because it combines glyburide and Glucophage (metformin hydrochloride tablets) -- the two most widely prescribed oral anti-diabetic agents -- in one convenient pill. These two agents work together to improve blood sugar control. Glucovance, along with diet and exercise, has been shown in clinical trials to provide better blood sugar control than either medication alone.
In return for conducting the FDA-requested pediatric studies, the law provides for a six-month extension of the exclusivity of the drug. In the case of Glucovance, exclusivity can be extended from July 31, 2003 to January 31, 2004.
In rare cases, Glucophage or Glucovance may cause lactic acidosis (buildup of lactic acid in the blood), which is serious and can be fatal in half the cases. This occurs mainly in people whose kidneys are not functioning properly. Patients should tell their doctor about their alcohol use because it can affect their risk. Patients should not take these drugs if they: have kidney problems, are 80 or older (unless they have their kidneys tested), are taking medication for heart failure, are seriously dehydrated, have a severe infection, or if they have or have had liver disease. The most common side effect is diarrhea. Symptoms of hypoglycemia (low blood sugar) such as light-headedness, dizziness, shakiness or hunger may also occur.